Manager/Group Leader- E&L

Key Responsibilities:

• Lead and manage a team of 10+ scientists (Ph.D. and M.Sc.) ensuring scientific excellence and operational efficiency.
• Extensive knowledge and application of Extractable and Leachable (E&L) testing in compliance with USP monographs and ISO guidelines for medical devices.
• Oversee operation and maintenance of multiple analytical instruments including LC-MS/MS, GC-MS/MS, ICP-MS, and Ion Chromatography.
• Lead method development and validation on LC-MS/MS, GC-MS/MS, and ICP-MS platforms.
• Prepare, review, and implement Standard Operating Procedures (SOPs) related to E&L, laboratory processes, and best practices.
• Ensure compliance with 21 CFR Part 11, data integrity principles, and good documentation practices within a cGMP laboratory environment.
• Monitor and manage daily laboratory operations, workflow, and resource allocation.
• Review and approve SOPs, Certificates of Analysis (COA), and other quality documentation.
• Utilize analytical techniques (NMR, IR, HPLC, GC, LC-MS) for structural elucidation and interpretation of results.
• Provide training, mentorship, and conflict resolution to foster a collaborative and high-performing team environment.
• Promote laboratory safety and ensure adherence to Safety, Health, and Environmental (SHE) standards.